The invention generally relates systems and methods for arresting or controlling the bleeding or leakage of fluid in body tissues, e.g., diffuse organ bleeding, lung punctures, anastomotic leakage, and the like.
Hemostatic barriers are routinely called upon to control bleeding. The bleeding may be caused by trauma, e.g. splenic, kidney, and liver lacerations, or may be caused during surgery, e.g. tumor removal or bone bleeding.
Bleeding is conventionally controlled by the application of solid sheets of material, e.g. gauze, Gelfoam(trademark) material, or Surgicel(trademark) material. These materials can be soaked with a hemostatic agent, such as thrombin or epinephrine, or sprayable formulations such as fibrin glue.
Conventional treatment modalities require the use of these hemostatic agents in conjunction with pressure to achieve hemostasis. The various hemostatic agents can include coagulation factors (e.g. thrombin), platelet activators (e.g. collagen), vasoconstrictors (epinephrine), or fibrinolytic inhibitors.
In some instances, conventional treatments achieve hemostasis in a clinically acceptable time. Still, there are a number of drawbacks.
For example, many treatment modalities consist of bovine collagen and bovine thrombin to cause the desired clotting action. These products have the potential for the transmission to humans of bovine spongiform encephalopathy (also called xe2x80x9cMad Cow Diseasexe2x80x9d). Regardless, the bovine thrombin marketed today is relatively impure, and these impurities can lead to complications in certain patient populations. Furthermore, fibrin glue, generally composed of purified fibrinogen and thrombin from pooled human blood, has safety and efficacy concerns as well. Additionally, many products do not achieve hemostasis in a clinically acceptable period, particularly in cases of brisk bleeding.
In addition to hemostatic agents, surgical sealants are also commonly used to control bleeding or fluid leakage along anastomoses formed by suture or staple lines, e.g., between blood vessels, bowel, or lung tissue. In cases of blood leakage, fibrin glue can be utilized to seal an anastomosis. Still, fibrin glue""s lack of adhesion to moist tissue, safety concerns, and cost precludes its widespread use as a surgical sealant for blood vessel anastomoses.
Conventional hemostatic agents and surgical sealants for blood vessel anastomoses achieve hemostasis using the application of pressure and by activating the coagulation pathway of the blood. Yet, many of the surgeries where hemostatic barriers and surgical sealants are required also require the administration of anti-coagulation therapies, such as heparin. The hemostatic barrier or surgical sealant, which is promoting coagulation, is hindered by the effect of the heparin, which is preventing coagulation.
Despite conventional treatment modalities for hemostatic barriers and surgical sealants, there is a need for a biomaterial that safely, quickly, and reliably arrests or controls fluid leakage in body tissues through the application of pressure and without interaction with the patient""s coagulation pathways.
The invention provides compositions, instruments, systems, and methods, which arrest or control bleeding or leakage of fluid in body tissue.
According to one aspect of the invention, a biocompatible and biodegradable material is provided which comprises a hydrogel compound free of a hemostatic agent and which, when applied by instruments, systems, and methods that embody the invention, arrests the flow of blood or fluid from body tissue.
According to another aspect of the invention, a biocompatible and biodegradable material is provided which comprises a hydrogel compound free of a hemostatic agent and which, when applied by instruments, systems, and methods that embody the invention,arrests organ diffuse bleeding.
According to another aspect of the invention, a biocompatible and biodegradable material is provided which comprises a protein solution and a polymer solution including a derivative of a hydrophilic polymer with a functionality of at least three, which, when mixed by instruments, systems, and methods that embody the invention, form a mechanical non-liquid covering structure that arrests the flow of blood or seals tissue.
Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended claims.